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Optimizing a Mobile Mindfulness Intervention for ICU Survivors (LIFT2)

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ClinicalTrials.gov Identifier: NCT04038567
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : April 21, 2020
Sponsor:
Collaborators:
University of Washington
University of Colorado, Denver
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE July 24, 2019
First Posted Date  ICMJE July 31, 2019
Last Update Posted Date April 21, 2020
Actual Study Start Date  ICMJE August 15, 2019
Estimated Primary Completion Date October 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
  • Change in Patient Health Questionnaire-9 Item scale (PHQ-9) [ Time Frame: Between baseline and 1 month post-randomization ]
    Depression symptoms. Scores range from 0 (better) to 27 (worse)
  • Change in Generalized Anxiety Disorder 7-item scale (GAD-7) [ Time Frame: Between baseline and 1 month post-randomization ]
    Anxiety symptoms. Scores range from 0 (better) to 21 (worse)
  • Change in Post-Traumatic Stress Symptom inventory (PTSS) [ Time Frame: Between baseline and 1 month post-randomization ]
    Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst).
  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: 1 month post-randomization ]
    A measure of acceptability. Scores can range from 8 (worst) to 32 (best)
  • Systems Usability Scale (SUS) [ Time Frame: 1 month post-randomization ]
    A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score. For each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
  • Change in Patient Health Questionnaire-9 Item scale (PHQ-9) [ Time Frame: Between baseline 3 months post-randomization ]
    Depression symptoms. Scores range from 0 (better) to 27 (worse)
  • Change in Generalized Anxiety Disorder 7-item scale (GAD-7) [ Time Frame: Between baseline 3 months post-randomization ]
    Anxiety symptoms. Scores range from 0 (better) to 21 (worse)
  • Change in Post-Traumatic Stress Symptom inventory (PTSS) [ Time Frame: Between baseline 3 months post-randomization ]
    PTSD symptoms. Scores can range from 10 (best) to 70 (worst).
  • Intervention adherence [ Time Frame: 1 month post-randomization ]
    Quantified by number of intervention sessions, weekly surveys, and intervention elements (e.g., videos, audio) completed.
  • Intervention adherence [ Time Frame: 3 months post-randomization ]
    Quantified by number of intervention sessions, weekly surveys, and intervention elements (e.g., videos, audio) completed.
  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: 3 months post-randomization ]
    A measure of acceptability. Scores can range from 8 (worst) to 32 (best)
  • Systems Usability Scale (SUS) [ Time Frame: 3 months post-randomization ]
    A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score. For each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best)
  • Change in Mindful Attention Awareness Scale (MAAS) [ Time Frame: Between baseline and 1 month post-randomization ]
    A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).
  • Change in Mindful Attention Awareness Scale (MAAS) [ Time Frame: Between baseline 3 months post-randomization ]
    A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).
  • Change in Patient Health Questionnaire 10-item scale (PHQ-10) [ Time Frame: Between baseline and 1 month post-randomization ]
    An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).
  • Change in Patient Health Questionnaire 10-item scale (PHQ-10) [ Time Frame: Between baseline 3 months post-randomization ]
    An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).
  • Change in EuroQOL scale [ Time Frame: Between baseline and 1 month post-randomization ]
    A measure of quality of life. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 0 (worst) to 100 (best)
  • Change in EuroQOL scale [ Time Frame: Between baseline 3 months post-randomization ]
    A measure of quality of life. Scores can range from 0 (worst) to 100 (best)
  • Distress associated with depression symptom frequency [ Time Frame: Between baseline and 1 month post-randomization ]
    A visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst)
  • Distress associated with depression symptom frequency [ Time Frame: Between baseline 3 months post-randomization ]
    A visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst)
  • Distress associated with anxiety symptom frequency [ Time Frame: Between baseline and 1 month post-randomization ]
    A visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst)
  • Distress associated with anxiety symptom frequency [ Time Frame: Between baseline 3 months post-randomization ]
    A visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst)
  • Distress associated with PTSD symptom frequency [ Time Frame: Between baseline and 1 month post-randomization ]
    A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst)
  • Distress associated with PTSD symptom frequency [ Time Frame: Between baseline 3 months post-randomization ]
    A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing a Mobile Mindfulness Intervention for ICU Survivors
Official Title  ICMJE Optimizing a Self-directed Mobile Mindfulness Intervention for Improving Cardiorespiratory Failure Survivors' Psychological Distress
Brief Summary This is a factorial experimental trial involving adult survivors of cardiorespiratory failure treated in intensive care units (ICUs) that is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. This will allow optimization of a mobile mindfulness intervention by comparing eight different iterations across domains including impact on symptoms, feasibility, acceptability, usability, scalability, and cost.
Detailed Description

As survival has improved for the 2 million people with cardiorespiratory failure managed annually in US intensive care units (ICUs), it has become apparent that these patients suffer from severe and persistent post-discharge symptoms of psychological distress including depression, anxiety, and post-traumatic stress disorder (PTSD). However, few targeted interventions exist that are relevant to patients' experiences and that accommodate their many physical, social, and financial barriers to personalized care. To fill this gap, an innovative app-based mobile mindfulness training program twas developed hat promotes automated care delivery and self-management of symptom-related distress.

Subsequently, a pilot randomized clinical trial (RCT) called the LIFT study (R34 AT00819) compared mobile mindfulness to both a standard telephone mindfulness program and an ICU education control among survivors of cardiorespiratory failure. Key findings were that mobile mindfulness was feasibly delivered, acceptable, usable, and had a greater clinical impact on psychological distress than either comparator. This trial also highlighted opportunities to improve the intervention's impact related to its targeted population, content delivery, and system technology.

To address these gaps, this 5-year project is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. It will optimize mobile mindfulness with four specific aims as described in the following sections. At the conclusion of this factorial randomized clinical trial study involving 152 cardiorespiratory failure survivors, a mobile mindfulness system fully optimized for usability, efficiency, scalability, and clinical impact will be delivered that will be off-the-shelf ready for a next-step definitive RCT—and can serve as a model for distance-based mind and body interventions.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Factorial experimental trial as part of a multi-phase optimization strategy (MOST) design
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
PIs and analysts blinded to allocation. Outcomes completed by participants using web-based interface and thus outcomes assessors as such are blinded.
Primary Purpose: Supportive Care
Condition  ICMJE Cardiorespiratory Failure
Intervention  ICMJE Behavioral: Mobile mindfulness-based training
The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.
Study Arms  ICMJE
  • Experimental: High dose / therapist attention / introductory call
    Will receive high dose intervention content, therapist attention to elevated symptoms, and an introductory call from a therapist.
    Intervention: Behavioral: Mobile mindfulness-based training
  • Experimental: High dose / therapist attention / no introductory call
    Will receive high dose intervention content, therapist attention to elevated symptoms, and no introductory call from a therapist.
    Intervention: Behavioral: Mobile mindfulness-based training
  • Experimental: High dose / app attention / introductory call
    Will receive high dose intervention content, app-based attention to elevated symptoms, and an introductory call from a therapist.
    Intervention: Behavioral: Mobile mindfulness-based training
  • Experimental: High dose / app attention / no introductory call
    Will receive high dose intervention content, app-based attention to elevated symptoms, and no introductory call from a therapist.
    Intervention: Behavioral: Mobile mindfulness-based training
  • Experimental: Standard dose / therapist attention / introductory call
    Will receive standard dose intervention content, therapist-based attention to elevated symptoms, and an introductory call from a therapist.
    Intervention: Behavioral: Mobile mindfulness-based training
  • Experimental: Standard dose / therapist attention / no introductory call
    Will receive standard dose intervention content, therapist-based attention to elevated symptoms, and no introductory call from a therapist.
    Intervention: Behavioral: Mobile mindfulness-based training
  • Experimental: Standard dose / app attention / introductory call
    Will receive standard dose intervention content, app-based attention to elevated symptoms, and an introductory call from a therapist.
    Intervention: Behavioral: Mobile mindfulness-based training
  • Experimental: Standard dose / app attention / no introductory call
    Will receive standard dose intervention content, app-based attention to elevated symptoms, and no introductory call from a therapist.
    Intervention: Behavioral: Mobile mindfulness-based training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2020)
152
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2019)
240
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date October 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA

  1. Adult (age ≥18)
  2. Acute cardiorespiratory failure:*

    • Acute respiratory failure, defined as ≥1 of the following:
    • mechanical ventilation via endotracheal tube for ≥12 hours
    • non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute respiratory failure in an ICU (not for obstructive sleep apnea or other stable use)
    • high flow nasal cannula or face mask for ≥4 hours in a 24-hour period and / or
    • Acute cardiac / circulatory failure, defined as ≥1 of the following:
    • use of vasopressors for shock of any etiology for ≥1 hour
    • use of inotropes for shock of any etiology for ≥1 hour
    • use of aortic balloon pump for cardiogenic shock for ≥1 hour

      • In an ICU setting, NOT including the operating room or emergency department.
  3. ICU setting: managed in an adult medical cardiac, trauma, surgical, or neurological ICU for ≥24 hours during the time inclusion criterion #2 is met.
  4. Cognitive status intact

    • No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart
    • Absence of current significant cognitive impairment (impairment defined as ≥3 errors on the Callahan cognitive status screen)
    • Decisional capacity present
  5. Absence of severe and/or persistent mental illness

    • Treatment for severe and/or persistent mental illness (e.g., psychosis, bipolar affective disorder, schizoaffective disorder, schizoid personality disorder, schizophrenia [as per medical record], hospitalization for any psychiatric disorder) within the 6 months preceding the current hospital admission
    • No endorsement of suicidality at time of admission or informed consent
    • No active substance abuse within the 3 months preceding the current admission serious enough to limit completion of study procedures in the opinion of the site investigator.
  6. English fluency.

EXCLUSION CRITERIA (in hospital):

  1. Hospitalized within the preceding 3 months with life-threatening illness or injury.

    Patients may be enrolled into the study if they had a hospitalization within the preceding 3 months that is determined to be non-serious. Non-serious admissions are defined as those admissions that are non-life threatening and/or potentially impacting patient's well-being long-term or likely to precipitate additional future admissions. Examples of non-life-threatening hospitalizations could be, but may not be limited to, admission for a bronchoscopy, admission for deep vein thrombosis, or admission to ED resulting in overnight stay for cardiac work-up.

  2. Admitted from a location other than home (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility)
  3. Anticipated or actual discharge to a location other than independent in a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility, home hospice)
  4. Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, disruptive chemotherapy/radiation regimen)
  5. Unable to complete study procedures as determined by staff
  6. Lack of reliable smartphone with cellular data plan or wifi access

    EXCLUSION CRITERIA (at T1, post-discharge):

  7. Low baseline psychological distress symptoms, defined as the absence of the following at T1: PHQ-9 score <5
  8. Failure to randomize within 2 month (60 days) post-discharge.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christopher Cox, MD 9196817232 christopher.cox@duke.edu
Contact: Allie Frear 9196848914 allie.frear@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04038567
Other Study ID Numbers  ICMJE Pro00100252
1U01AT009974 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We will follow NIH/NCCIH guidelines for data access.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: We will follow NIH and institutional guidelines.
Access Criteria: We will follow NIH and institutional guidelines. Given the length of time that will elapse during the study, we will need to adhere to the rules present at that time.
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • University of Washington
  • University of Colorado, Denver
  • National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Christopher E Cox, MD Duke University
PRS Account Duke University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP